D-0539-2023 Class II Ongoing

Recalled by Ascend Laboratories, LLC — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
April 26, 2023
Initiation Date
March 17, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
135 bottles

Product Description

Aripiprazole Tablets, USP, 20 mg, Rx Only, Packaged in 500-count bottle Manufactured by: Alkem Laboratories Ltd., INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC#: 67877-434-05

Reason for Recall

Out of specification (OOS) for Spectroscopic Identification test by IR.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #22143120, Exp. Date: June 2024